Events

Retiro De Equipo (Recall) de Infinity Enteral Feeding infusion pump

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por MOOG Medical Devices Group.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63485
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0764-2013
  • Fecha de inicio del evento
    2012-10-12
  • Fecha de publicación del evento
    2013-01-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113975
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pump, infusion, enteral - Product Code LZH
  • Causa
    The firm is adding an addendum to the operator's manual for infinity enteralite ambulatory feeding pumps pertaining to the infinite dose mode and the inability of the pump to detect air in line.
  • Acción
    An Urgent Field Safety Notice was sent to all original consignees by certified mail beginning on Monday, October 15, 2012. Consignees were provided with an Addendum to the Operator's Manual as part of the Notice. Consignees were instructed to assure pump users are aware of the information in the addendum and to store the addendum with the Operator's Manual. Consignees were also requested to complete and return a Medical Device Recall reply form to the firm. For additional information or clarification, consignees are to contact Holly Imes, Manager, Regulatory Affairs at 801-264-1001, ext. 230 or via email at: himesstark@moog.com.

Device

Infinity Enteral Feeding infusion pump
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution and US Nationwide in the countries of (Germany, Sweeden, Croatia, Lithuania, and Dubai).
  • Descripción del producto
    Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual || Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
  • Manufacturer
    MOOG Medical Devices Group

Manufacturer

MOOG Medical Devices Group
  • Dirección del fabricante
    MOOG Medical Devices Group, 4314 Zevex Park Ln, Salt Lake City UT 84123-7881
  • Empresa matriz del fabricante (2017)
    Moog Inc
  • Source
    USFDA